U.S. Early Access Programs Operations Lead

Boehringer Ingelheim; Ridgefield (CT); On-site; USD 166,000 - 248,000; Full time

Job summary

Boehringer Ingelheim is seeking a U.S. Early Access Program Manager to translate the global EAT framework into coordinated U.S. implementation.

This role collaborates with Clinical Development, Regulatory Affairs, Patient Safety, Quality, and external partners to deliver timely, inspection-ready execution of EAP/OOS activities. The incumbent will lead centralized PM activities, support Local EAP Coordinators, and manage vendor relationships, while ensuring compliance with FDA expanded access

Qualifications

• Bachelor's degree in a related scientific, business, or clinical discipline; MA/MS/MBA preferred.
• 7+ years of pharma/clinical operations experience with program-management focus.
• Experience coordinating complex cross-functional programs from planning to closeout.
• Knowledge of FDA expanded access regulations and ICH-GCP principles.

Responsibilities

• Lead centralized U.S. program management and operational enablement for EAP/OOS activities with integrated plans and governance.
• Provide PM support to Local EAP Coordinators; coordinate workplans, documentation, and system setup.
• Support Local TA OOS Leads; ensure alignment with approved guidance and registry.
• Develop and maintain U.S. implementation materials aligned with global framework.
• Coordinate compliance, quality, safety, and inspection-readiness across EAP/OOS operations.
• Lead adoption of BOOST and related systems; manage user onboarding and data quality.
• Oversee U.S. vendor and service-provider management for EAP/OOS; define requirements and SLAs.
• Develop operational reporting; monitor metrics, risks, and continuous-improvement opportunities.

Skills

Program Leadership

Vendor Management

Cross-functional Collaboration

Governance Clarity

Operational & Resource Management

Risk & Quality Management

Data Fluency

Process Improvement

Education

Bachelor's degree required

Advanced degree preferred

Tools

BOOST

Veeva

Job description

Boehringer Ingelheim is seeking a U.S. Early Access Program Manager to translate the global EAT framework into coordinated U.S. implementation.

This role collaborates with Clinical Development, Regulatory Affairs, Patient Safety, Quality, and external partners to deliver timely, inspection-ready execution of EAP/OOS activities. The incumbent will lead centralized PM activities, support Local EAP Coordinators, and manage vendor relationships, while ensuring compliance with FDA expanded access